Recalls / —
—#48342
Product
Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
- FDA product code
- LXH — Orthopedic Manual Surgical Instrument
- Device class
- Class 1
- Medical specialty
- Orthopedic
- Affected lot / code info
- Catalog number 74018811 Lot Numbers: 06CM3493, 06CM03494, 06CM11279, 06CM11280, 06DM01843, 06DM01844, 06EM04235, 06EM04236, 06EM04237, 06EM07308, 06FM11461, 06FM11462, 06GM00024, 06GM00025, 06GM00026, 06GM00027, 06GM00028 Catalog number 74018813 Lot Numbers: 06CM03491, 06CM03492, 06CM03492A, 06DM09155, 06DM09156, 06DM09157, 06DM09158, 06DM12567, 06DM12568, 06DM12569, 06DM12570, 06DM12571, 06EM07309, 06EM07310, 06FM02041, 06FM02042, 06FM11464, 06FM11465, 06GM06530, 06GM06531 Catalog number 74018815 Lot Numbers 06CM03489, 06CM03490, 06CM03490A, 06CM11283, 06CM11284, 06DM01852, 06DM01853, 06DM09532, 06DM09534, 06DM09535, 06DM09536, 06FM11466, 06FM11467, 06GM00029, 06FM00030, 06GM00031, 06GM00032, 06GM06532, 06HM05954, 06HM05955, 06HM05956, 06HM05957, 06HM05958, 06HM05959 Catalog number 74018817 Lot Numbers: 06CM03486, 06CM03487, 06CM03488, 03CM03488A, 06CM12230, 06CM12231, 06DM01851, 06DM12572, 06DM12573, 06DM12574, 06DM12575, 06DM12576, 06FM11468, 06FM11469, 06GM00033, 06GM00034, 06GM00035, 06GM00036, 06GM10621
Why it was recalled
Tibial punches were not manufactured to specification and could break at the tip during use.
Root cause (FDA determination)
Other
Action the firm took
Recall notification was initiated by letter (Fed Ex) to domestic territory manager and sales representative and to international distributors (via email and telephone follow-up) on 08/29/2006 to request the return of any in stock product.
Recalling firm
- Firm
- Smith & Nephew Inc
- Address
- 1450 E Brooks Rd, Memphis, Tennessee 38116-1804
Distribution
- Distribution pattern
- Worldwide distribution ----- including USA and countries of Austria, Australia, Belgium, Canada, China, Dubai, France, Germany, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Portugal, Singapore, South Africa, South Korea, Spain, Turkey, United Kingdom, and Venezuela.
Timeline
- Recall initiated
- 2006-08-29
- Posted by FDA
- 2006-10-03
- Terminated
- 2010-04-12
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #48342. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.